Georgia Doctor Pleads Guilty to Distributing Misbranded Weight Loss Drug Product

A Georgia physician pleaded guilty today to charges related to the sale of a purported weight loss drug product that contained human chorionic gonadotropin, or HCG.

Dr. Audrey Arona, 64, of Gainesville, Georgia, pleaded guilty to causing the introduction into interstate commerce of a misbranded drug product containing HCG and marketed under the name "Releana." Pursuant to a plea agreement, Magistrate Judge J. Clay Fuller of the United States District Court for the Northern District of Georgia ordered Dr. Arona to forfeit approximately $65,000.

HCG is a hormone produced by the human placenta. The U.S. Food and Drug Administration (FDA) has approved certain injectable HCG drug products for the treatment of some cases of female infertility and for hormone treatment in males. But the FDA has never approved any oral or sublingual HCG drug products for any use, and the FDA has never approved any HCG drug product for weight loss. In fact, FDA has specifically warned consumers to avoid HCG weight-loss products, advising, "If you have HCG products for weight loss, quit using it, throw it out, and stop following the dieting instructions."

"Doctors who distribute drugs must comply with federal law designed to ensure these products are safe and effective," said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department's Civil Division. "The Department will continue to work closely with our law enforcement partners to stop the distribution of misbranded HCG drugs and other misbranded drugs, including through criminal enforcement where appropriate."

"Misbranded prescription drugs can present a serious health risk to those who buy and use them. The drugs may contain unknown ingredients and may be made under unknown conditions," said Special Agent in Charge Charles L. Grinstead of the FDA Office of Criminal Investigations Kansas City Field Office. "We will continue to investigate and bring to justice those who traffic in misbranded prescription drugs."

According to court documents, Dr. Arona admitted to selling a sublingually administered HCG-for-weight-loss drug product to patients around the country. Dr. Arona further admitted that she represented to patients that the HCG-for-weight-loss drug product was FDA-approved and that it could assist with weight loss.

Dr. Arona was the third defendant to plead guilty in connection with the marketing and sale of Releana. In September 2022, Hoschton, Georgia, resident Maurice Bailey also pleaded guilty to causing the introduction into interstate commerce of a misbranded drug product containing HCG. According to court documents, Bailey admitted to preparing the Releana sold by Dr. Arona in a facility that was not properly registered with FDA, and to inaccurately labelling that Releana. In August 2021, Colorado resident Sarah Alberg pleaded guilty to causing the introduction into interstate commerce of a misbranded drug product containing HCG, with the intent to mislead or defraud. According to court documents, Alberg also distributed Releana, and she admitted to smuggling HCG into the United States from India and distributing HCG using bottles and supplies exposed to rodent droppings.

The FDA Office of Criminal Investigations investigated the cases.

Senior Litigation Counsel Patrick Runkle and Trial Attorney Michael Wadden of the Justice Department's Consumer Protection Branch prosecuted the cases against Dr. Arona and Bailey, with assistance from Assistant U.S. Attorney Jennifer Keen for the Northern District of Georgia.

For more information about the enforcement efforts of the Consumer Protection Branch visit the Branch's website at http://www.justice.gov/civil/consumer-protection-branch